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This guidance sets out the clinical requirements based on the consensus of what is ‘minimally acceptable’ performance in the opinion of the anaesthesia and intensive care medicine professionals and medical device regulators.
Update on MHRA UK risk-based GxP inspection programme.
How to test and report levels of nicotine uptake when submitting a notification of intent to market e-cigarette and vape products in Great Britain.
Sets out opportunities for commissioners and providers to realise community pharmacy’s role in protecting and improving the nation's health.
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Provide innovators and developers of innovative products access to MHRA scientific expertise, regulatory guidance and an enhanced advice and signposting service.
How to best protect patients and volunteers during magnetic resonance imaging (MRI) examinations.
Outlines the aim, scope and definitions of the medical technology innovation classification framework.
Our Patient Involvement Strategy sets out how we will engage and involve the public and patients at every step of the regulatory journey.
Interventions that can be made by pharmacy teams, to improve quality of life for older people.
Sets out the payment due from members of the voluntary scheme for branded medicines pricing, access and growth in 2025.
Information for patients, public and healthcare professionals
Guidance on labelling requirements pertinent to the type of medicinal product and its supply status, as defined in UK legislation.
Guidance on applying for a Marketing Authorisation for Decentralised Manufacture, including eligibility, process, and requirements.
Guidance for industry on flexible approaches we are taking on good distribution practices.
If pharmacies wish to ‘pack down’ larger packs of a medicinal product, they need to follow these instructions
Industry must notify the MHRA if they will not be using these flexibilities
Sets out the process for pharmaceutical companies to appeal against decisions made by the Secretary of State for Health and Social Care.
Device-specific guidance for manufacturers on reporting adverse incidents under the vigilance system.
The call for applications for phase 2 of the AI Airlock is now closed.
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